Regulatory Affairs Professional

3 days ago

Allahabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

Job Opportunity:

We are currently seeking a detail-oriented professional to fill the role of Regulatory Affairs Associate, supporting global submissions and lifecycle management activities.

Key Responsibilities:

  • Prepare variation documents and evaluate post-approval CMC changes in compliance with international regulatory requirements.
  • Contribute to Lifecycle Management (LCM) by assisting in compiling and reviewing CTD dossier modules.
  • Compile initial dossiers for various countries, including the US, EU, SA, WHO, ANZ, and others.
  • Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Manage compilation and submission of variations/supplements for multiple countries.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Review technical documents from manufacturing sites, including:
  • Specifications
  • Batch Manufacturing Records
  • Process & Analytical Validations
  • Batch Analysis Data
  • Stability Data

Required Skills and Qualifications:

  • A minimum of 3 years of experience in managing initial submissions, variations, and full LCM deliverables for global markets.
  • Mandatory experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for various countries.
  • Hands-on experience in initial dossier compilation for various countries.
  • Experience in providing regulatory strategies/evaluations by performing assessments of post-approval CMC changes considering global regulatory requirements.

Why This Role is Important:

This position requires strong analytical and organizational skills, as well as excellent communication abilities. The ideal candidate will be able to work effectively in a team environment and demonstrate a high level of attention to detail.

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